The following data is part of a premarket notification filed by National Medical Care, Medical Products Div., Inc. with the FDA for Four Tank Dissolution Module.
Device ID | K864635 |
510k Number | K864635 |
Device Name: | FOUR TANK DISSOLUTION MODULE |
Classification | System, Dialysate Delivery, Central Multiple Patient |
Applicant | NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. TWO VOLVO DR. Rockleigh, NJ 07647 |
Contact | Del Donna |
Correspondent | Del Donna NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. TWO VOLVO DR. Rockleigh, NJ 07647 |
Product Code | FKQ |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-11-25 |
Decision Date | 1987-01-13 |